Written answers

Wednesday, 1 February 2017

Department of Health

Medicinal Products Availability

Photo of Jackie CahillJackie Cahill (Tipperary, Fianna Fail)
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277. To ask the Minister for Health the reason for the delay in the completion of the analysis of the cancer treating drug nivolumab by the NCPE (details supplied); and if he will make a statement on the matter. [4815/17]

Photo of Simon HarrisSimon Harris (Wicklow, Fine Gael)
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The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.

In line with the 2013 Act, if a Company would like a medicine to be reimbursed by the HSE pursuant to the Community Drug Schemes or as a hospital medicine, the Company must first submit an application to the HSE to have the new medicine added to the Reimbursement List or to be priced as a hospital medicine.

Within 180 days of receiving the application (or such longer period which may arise if further information is sought from the Company), the HSE will decide to either:

- add the medicine to the Reimbursement List/agree to reimburse it as a hospital medicine,

- or,

- will refuse to reimburse the medicine.

I am informed that the HSE received a request and economic dossier from the manufacturer of Nivolumab for the treatment of advanced renal cell carcinoma. At the request of the HSE, the National Centre for Pharmacoeconomics (NCPE) is currently conducting an assessment of Nivolumabfor the treatment of this indication. Once this assessment is completed, a summary report will be published on the NCPE website. The HSE will then consider the NCPE assessment as part of its decision-making process when considering the drug for reimbursement.

In reaching its decision, the HSE examines all the evidence which may be relevant in its view for the decision (including the information/dossier submitted by the Company) and will take into account such expert opinions and recommendations which may have been sought by the HSE at its sole discretion (for example, from the NCPE).

As the NCPE's assessment of Nivolumabis ongoing, it is not possible to provide further details at this time.

In relation to compassionate access schemes, I have previously asked manufacturers to show compassion and to maintain compassionate access schemes for patients during the assessment process by the HSE and this remains the position. However, the operation of these schemes is at the discretion of manufacturers. There is no provision in Irish legislation for the approval of compassionate use programmes for specific groups of patients with an unmet medical need.

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